Apparatus and method for targeted bronchial denervation by cryo-ablation

ABSTRACT

A method for performing bronchial denervation, the method comprising an electromyography system having a cryoablation device with at least two recording electrodes. The electromyography system being configured to calculate a difference between a first electromyogram signal received from the first recording electrode and a second electromyogram signal received from the second recording electrode to generate a recorded electromyogram and compare the recorded electromyogram to a reference electromyogram.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Continuation of U.S. application Ser. No.16/282,504, filed Feb. 22, 2019 and this application claims the benefitof U.S. Application Ser. No. 62/636,416, filed Feb. 28, 2018.

FIELD

The present technology is generally related to devices, systems, andmethods for treating pulmonary conditions, such as chronic obstructivepulmonary disease (COPD) and asthma, by denervating bronchial tissueusing cryoablation.

BACKGROUND

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatorylung disease that results in obstructed airflow within the lungs, andthe term is also used to refer to a family of pulmonary conditions, suchas emphysema and chronic bronchitis. COPD is the fourth leading cause ofdeath, with approximately one-third of all health-related expenses beingassociated with the condition. Asthma is believed to be a risk factorfor developing COPD, and patients with COPD may be more likely todevelop heart disease, lunch cancer, and other conditions. Researchindicates that COPD causes epithelial metaplasia, mucous metaplasia,fibrosis, increase in smooth muscle mass, and other conditions that, inaddition to the contractile nature of bronchial smooth muscle,contribute to airway obstruction. Additionally, bronchial smooth musclein patients with COPD is infiltrated by inflammatory cytokines,proteases, and growth factors, which further exacerbates airwayobstruction.

Denervation, or neural modulation, of the parasympathetic nervous system(PSNS) is a relatively new technique for treating conditions such ashypertension and cardiovascular disease in a minimally invasive way.However, there has been little research indicating the efficacy ofdenervation for other conditions, such as those affecting the lungs.Further, when performing denervation, care must be taken to avoiddamaging non-target tissue.

SUMMARY

Some embodiments advantageously provide devices, systems, and methodsfor treating pulmonary conditions, such as COPD, by denervatingbronchial tissue using cryoablation. In one embodiment, a device forbronchial denervation comprises: an elongate body having a distalportion and a proximal portion opposite the distal portion; a treatmentelement at the distal portion of the elongate body; and a firstrecording electrode located distal to the treatment element and a secondrecording electrode located proximal to the treatment element, the firstand second recording electrodes being configured to recordelectromyograms.

In one aspect of the embodiment, the treatment element includes at leastone balloon. In one aspect of the embodiment, the treatment elementincludes an equatorial portion, the treatment element further includinga fluid delivery element within the at least one balloon, the fluiddelivery element having a plurality of orifices that are aligned withthe equatorial portion of the treatment element. In one aspect of theembodiment, the plurality of orifices includes at least twenty-fourorifices radially arranged about the fluid delivery element, each of theat least twenty-four orifices having a diameter of between approximately0.0005 inch and approximately 0.0015 inch.

In one aspect of the embodiment, the at least twenty-four orifices areradially arranged about an entirety of a circumference of the fluiddelivery element.

In one aspect of the embodiment, the at least twenty-four orifices areradially arranged about a portion of a circumference of the fluiddelivery element.

In one aspect of the embodiment, the at least twenty-four orifices arehelically arranged about an entirety of a circumference of the fluiddelivery element.

In one aspect of the embodiment, the treatment element includes: aballoon having a plurality of lobes; and a plurality of splinesextending parallel to the longitudinal axis of the elongate body, theplurality of splines alternating with the plurality of lobes.

In one embodiment, a system for bronchial denervation comprises: acryoablation device including a treatment element and at least onerecording electrode; an electromyography system in communication withthe at least one recording electrode; and a control unit in fluidcommunication with the cryoablation device.

In one aspect of the embodiment, the cryoablation device furtherincludes a longitudinal axis, the treatment element including: a balloonhaving a plurality of lobes; and a plurality of splines extendingparallel to the longitudinal axis of the cryoablation device and betweenthe plurality of lobes.

In one aspect of the embodiment, the treatment element includes aflexible portion that is transitionable between an at leastsubstantially linear first configuration and an expanded secondconfiguration, the flexible portion having a helical configuration whenin the expanded second configuration.

In one aspect of the embodiment, the at least one recording electrodeincludes a first recording electrode located distal to the treatmentelement and a second recording electrode located proximal to thetreatment element.

In one aspect of the embodiment, the electromyography system includesprocessing circuitry configured to: receive electromyogram signals fromthe at least one recording electrode; calculate a difference between afirst electromyogram signal received from the first recording electrodeand a second electromyogram signal received from the second recordingelectrode to generate a recorded electromyogram; and compare therecorded electromyogram to a reference electromyogram.

In one aspect of the embodiment, the processing circuitry is furtherconfigured to determine whether denervation has occurred in an area oftargeted tissue proximate the treatment element based on the comparisonbetween the recorded electromyogram and the reference electromyogram.

In one aspect of the embodiment, the processing circuitry is furtherconfigured to generate an alert when the processing circuitry hasdetermined that denervation has occurred in the area of targeted tissueproximate the treatment element.

In one aspect of the embodiment, the control unit includes a coolantsource, the coolant source being in fluid communication with thetreatment element.

In one embodiment, a method for performing bronchial denervationcomprises: positioning a treatment element of a cryoablation devicewithin a bronchus of a patient's lung; expanding the treatment elementsuch that at least a portion of the treatment element is in contact withat least a portion of at least one of bronchial tissue and nervesinnervating the bronchial tissue; circulating coolant within thetreatment element to reduce a temperature of the treatment element to atemperature sufficient to cryoablate the at least a portion of the atleast one of bronchial tissue and nerves innervating bronchial tissue;recording at least one electromyogram signal from the at least a portionof the at least one of bronchial tissue and nerves innervating bronchialtissue with each of a first recording electrode and a second recordingelectrode; and transmitting the recorded at least one electromyogramsignal to an electromyography system.

In one aspect of the embodiment, the method further comprises:calculating a difference between the at least one electromyogram signalreceived from the first recording electrode and the at least oneelectromyogram signal received from the second recording electrode togenerate a recorded electromyogram; comparing the recordedelectromyogram to a reference electromyogram; determining whetherdenervation has occurred in the at least a portion of the at least oneof bronchial tissue and nerves innervating bronchial tissue based on thecomparison; and discontinuing the circulation of coolant within thetreatment element when it is determined that denervation has occurred inthe at least a portion of the at least one of bronchial tissue andnerves innervating bronchial tissue.

In one aspect of the embodiment, the method further comprises:generating an alert when it is determined that denervation has occurredin the at least a portion of the at least one of bronchial tissue andnerves innervating bronchial tissue.

In one aspect of the embodiment, the treatment element includes at leastone balloon, expanding the treatment element including inflating theballoon.

In one aspect of the embodiment, the at least one balloon includes: aballoon having a plurality of lobes; and a plurality of splinesextending between the plurality of lobes.

In one embodiment, a method for performing bronchial denervation, themethod comprising an electromyography system having a cryoablationdevice with at least two recording electrodes. The electromyographysystem being configured to calculate a difference between a firstelectromyogram signal received from the first recording electrode and asecond electromyogram signal received from the second recordingelectrode to generate a recorded electromyogram and compare the recordedelectromyogram to a reference electromyogram.

In one aspect of the embodiment, the method further comprisestransmitting the first electromyogram signal and the secondelectromyogram signal to the electromyography system.

In one aspect of the embodiment, the at least two recording electrodesincludes a first recording electrode and a second recording electrode,when the cryoablation device is performing a cryoablation procedure thefirst recording electrode and the second recording electrode arecontinuously transmitting signals to the electromyography system.

In one aspect of the embodiment, the method further includes calculatinga voltage difference between the first electromyogram signal and thesecond electromyogram signal.

In one aspect of the embodiment, the at least two recording electrodesincludes a first recording electrode and a second recording electrodeand before the cryoablation device is performing a cryoablationprocedure, the first recording electrode and the second recordingelectrode are continuously transmitting signals to the electromyographysystem.

In one aspect of the embodiment, the at least two recording electrodesincludes a first recording electrode and a second recording electrodeand while the cryoablation device performs a cryoablation procedure andafter the cryoablation device performs a cryoablation procedure, thefirst recording electrode and the second recording electrode arecontinuously transmitting signals to the electromyography system.

In one aspect of the embodiment, the at least two recording electrodesincludes a first recording electrode and a second recording electrode.The calculation further includes calculating a difference between thefirst electromyogram signal received from the first recording electrodeand the second electromyogram signal received from the second recordingelectrode before a cryoablation procedure to generate a first recordedelectromyogram and calculating the difference between the firstelectromyogram signal received from the first recording electrode andthe second electromyogram signal received from the second recordingelectrode after cryoablation to generate a second recordedelectromyogram.

In one aspect of the embodiment, the method further comprisescalculating the difference between the first recorded electromyogram andthe second recorded electromyogram.

In one aspect of the embodiment, the method further comprises comparingthe calculated difference between the first recorded electromyogram andthe second recorded electromyogram with a reference electromyogram.

In one aspect of the embodiment, the method further comprisesdetermining whether denervation has occurred based on the comparisonbetween the difference between the first recorded electromyogram and thesecond recorded electromyogram with the reference electromyogram.

In one aspect of the embodiment, the electromyography system determinesthat denervation has occurred when the comparison between the differencebetween the first recorded electromyogram and the second recordedelectromyogram with the reference electromyogram exceeds a thresholddifference.

In one aspect of the embodiment, the method further comprises generatingan alert when the electromyography system determines that denervationhas occurred.

In one aspect of the embodiment, the alert is an audible or visualalert.

In one embodiment, a method for performing bronchial denervation wherethe method comprises a cryoablation device including a treatment elementand a first recording electrode and a second recording electrode and anelectromyography system in communication with the at least the firstrecording electrode and the second recording electrode. Theelectromyography system including processing circuitry configured toreceive electromyogram signals from the first recording electrode andthe second recording electrode, calculate a difference between a firstelectromyogram signal received from the first recording electrode and asecond electromyogram signal received from the second recordingelectrode to generate a recorded electromyogram, and compare therecorded electromyogram to a reference electromyogram.

In one aspect of the embodiment, the processing circuitry is furtherconfigured to determine whether denervation has occurred in an area oftissue based on the comparison between the recorded electromyogram andthe reference electromyogram.

In one aspect of the embodiment, the processing circuitry is furtherconfigured to generate an alert when the processing circuitry hasdetermined that denervation has occurred in an area of tissue.

In one embodiment, a method for performing bronchial denervation, themethod comprising positioning a treatment element proximate an area oftargeted tissue, expanding the treatment element such that at least aportion of the treatment element is in contact the area of targetedtissue, circulating a coolant within the treatment element to reduce atemperature of the treatment element to a temperature sufficient tocryoablate at least a portion of the area of targeted tissue, recordingat least one electromyogram signal from the at least a portion of thearea of targeted tissue with each of a first recording electrode and asecond recording electrode, transmitting the recorded at least oneelectromyogram signal to an electromyography system, calculating adifference between the at least one electromyogram signal received fromthe first recording electrode and the at least one electromyogram signalreceived from the second recording electrode to generate a recordedelectromyogram, and comparing the recorded electromyogram to a referenceelectromyogram.

In one aspect of the embodiment, the method further comprisesdetermining whether denervation has occurred in the at least a portionof the area of targeted tissue based on the comparison and discontinuingthe circulation of the coolant within the treatment element when it isdetermined that denervation has occurred in the area of targeted tissue.

In one aspect of the embodiment, the method further comprises generatingan alert when it is determined that denervation has occurred in the atleast a portion of the area of targeted tissue.

In one aspect of the embodiment, the electromyography system furtherincludes processing circuitry configured to determine whetherdenervation has occurred in the area of targeted tissue based on thecomparison between the recorded electromyogram and the referenceelectromyogram.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 shows an exemplary system for bronchial denervation; the systemincluding a cryoablation device;

FIG. 2 shows a partial cross-sectional view of an exemplary cryoablationdevice in accordance with the present disclosure;

FIG. 3 shows an exemplary cryoablation device having an exemplaryembodiment of a fluid delivery element in accordance with the presentdisclosure;

FIG. 4 shows an exemplary cryoablation device having another exemplaryembodiment of a fluid delivery element in accordance with the presentdisclosure;

FIG. 5A shows a side view of an exemplary embodiment of a fluid deliveryelement in accordance with the present disclosure;

FIG. 5B shows a cross-sectional view of the fluid delivery element ofFIG. 5A in accordance with the present disclosure;

FIG. 6A shows a side view of another exemplary embodiment of a fluiddelivery element in accordance with the present disclosure;

FIG. 6B shows a cross-sectional view of the fluid delivery element ofFIG. 6A in accordance with the present disclosure;

FIG. 7A shows a side view of another exemplary embodiment of a fluiddelivery element in accordance with the present disclosure;

FIG. 7B shows a cross-sectional view of the fluid delivery element ofFIG. 7A in accordance with the present disclosure;

FIG. 8 shows a side view of another exemplary cryoablation device inaccordance with the present disclosure;

FIG. 9 shows a front view of the exemplary embodiment of thecryoablation device of FIG. 8 in accordance with the present disclosure;

FIG. 10 shows a side view of another exemplary embodiment of acryoablation device in accordance with the present disclosure;

FIG. 11 shows a side view of another exemplary embodiment of acryoablation device in a delivery configuration in accordance with thepresent disclosure;

FIG. 12 shows a side view of exemplary embodiment of the cryoablationdevice of FIG. 11 in an expanded configuration in accordance with thepresent disclosure;

FIG. 13 shows a cryoablation device positioned at an exemplary treatmentsite within a bronchus in accordance with the present disclosure;

FIG. 14 shows an exemplary lesion pattern created within a bronchus by acryoablation device in accordance with the present disclosure;

FIG. 15 shows another exemplary lesion pattern created within a bronchusby a cryoablation device in accordance with the present disclosure;

FIG. 16 shows another exemplary lesion pattern created within a bronchusby a cryoablation device in accordance with the present disclosure;

FIG. 17 shows another exemplary lesion pattern created within a bronchusby a cryoablation device in accordance with the present disclosure;

FIG. 18 shows an exemplary electromyogram before bronchial denervation;

FIG. 19 shows another exemplary electromyogram after bronchialdenervation in accordance with the present disclosure; and

FIG. 20 shows an exemplary method of performing bronchial denervationusing a cryoablation device in accordance with the present disclosure.

DETAILED DESCRIPTION

Before describing in detail exemplary embodiments, it is noted that theembodiments reside primarily in combinations of apparatus components andprocessing steps related to performing a denervation procedure.Accordingly, the system and method components have been representedwhere appropriate by conventional symbols in the drawings, showing onlythose specific details that are pertinent to understanding theembodiments of the present disclosure so as not to obscure thedisclosure with details that will be readily apparent to those ofordinary skill in the art having the benefit of the description herein.Moreover, while certain embodiments or figures described herein mayillustrate features not expressly indicated in other figures orembodiments, it is understood that the features and components of thesystem and devices disclosed herein are not necessarily exclusive ofeach other and may be included in a variety of different combinations orconfigurations without departing from the scope and spirit of theinvention.

As used herein, relational terms, such as “first” and “second,” “top”and “bottom,” and the like, may be used solely to distinguish one entityor element from another entity or element without necessarily requiringor implying any physical or logical relationship or order between suchentities or elements. The terminology used herein is for the purpose ofdescribing particular embodiments only and is not intended to belimiting of the concepts described herein. As used herein, the singularforms “a”, “an” and “the” are intended to include the plural forms aswell, unless the context clearly indicates otherwise. It will be furtherunderstood that the terms “comprises,” “comprising,” “includes” and/or“including” when used herein, specify the presence of stated features,integers, steps, operations, elements, and/or components, but do notpreclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this disclosure belongs. It willbe further understood that terms used herein should be interpreted ashaving a meaning that is consistent with their meaning in the context ofthis specification and the relevant art and will not be interpreted inan idealized or overly formal sense unless expressly so defined herein.

In embodiments described herein, the joining term, “in communicationwith” and the like, may be used to indicate electrical or datacommunication, which may be accomplished by physical contact, induction,electromagnetic radiation, radio signaling, infrared signaling oroptical signaling, for example. One having ordinary skill in the artwill appreciate that multiple components may interoperate andmodifications and variations are possible of achieving the electricaland data communication.

The parasympathetic nervous system (PSNS), one branch of the autonomicnervous system, is involved in the parasympathetic control of the lungs.Activation of the PSNS causes postganglionic parasympathetic fibers torelease acetylcholine, which results in constriction of the smoothmuscle surrounding the bronchi and, in turn, the reduction of airflow.Denervation of the bronchi of the lung using cryoablation may be a safeand effective means for treating COPD and asthma. Many other largernerves (for example, between 100 and 250 μm) are located within 5 mm ofthe inner surface of the bronchi. As discussed herein, cryoablatingtarget nerve tissue in or along the bronchial wall radially outward froma tissue location may reduce airway resistance through the bronchus.Using cryoablation may minimize structural tissue damage in thebronchial wall of the airway while denervating parasympathetic nerve(s)around the bronchi and decreasing activity (and constriction) of thesmooth muscle.

Referring now to FIG. 1, an exemplary medical system 10 for bronchialdenervation is shown. New research indicates that denervation within thelung using cryoablation is a safe and effective means for treatingconditions such as COPD and asthma and, consequentially, for potentiallyreducing the risk of developing other conditions, such as heart diseaseand lung cancer. In one embodiment, the medical system 10 generallyincludes a treatment device, such as a cryoablation device 12, havingone or more treatment elements 14, and a control unit 16 incommunication with the cryoablation device 12. In one embodiment, themedical system 10 also includes an electromyography system 18 incommunication with the cryoablation device 12 and the control unit 16.Although the cryoablation device 12 is described herein as operating toreduce the temperature of target tissue in order to ablate nerves withinthe lungs, it will be understood that the cryoablation device 12 alsomay be used with one or more additional modalities, such asradiofrequency (RF) ablation, pulsed field ablation, ultrasoundablation, microwave ablation, or the like. Additionally, thecryoablation device 12 may be used for treatment, denervation, or nervemodulation of other locations within the patient's body, such as theheart.

The one or more treatment elements 14 are configured to delivercryogenic therapy, and may further be configured to deliverradiofrequency energy, pulsed field ablation energy, or the like forenergetic transfer with the area of targeted tissue, such as pulmonarytissue. In particular, the treatment element(s) 14 are configured toreduce the temperature of adjacent tissue in order to performcryotreatment and/or cryoablation and, consequently, denervation. Forexample, the treatment elements(s) 14 may include one or more balloons20 (as shown in FIG. 1) within which a coolant may be circulated inorder to reduce the temperature of the balloon 20. Additionally, thetreatment element(s) 14 may include other thermally and/orelectrically-conductive components, such as one or more electrodes incommunication with the control unit 16 (not shown).

In the embodiment shown in FIGS. 1 and 2, the cryoablation device 12includes a handle 22 and an elongate body 24 coupled to the handle 22.The elongate body 24 is sized and configured to be passable through apatient's vasculature and/or positionable proximate to a tissue regionfor diagnosis or treatment, such as a catheter, sheath, or intravascularintroducer. The elongate body 24 defines a longitudinal axis 26, aproximal portion 28, and a distal portion 30, and may further includeone or more lumens disposed within the elongate body 24 that providemechanical, electrical, and/or fluid communication between the proximalportion 28 of the elongate body 24 and the distal portion 30 of theelongate body 24. Further, the treatment element(s) 14 (such as theballoon(s) 20 shown in FIGS. 1 and 2) are coupled to the elongate bodydistal portion 30. In one embodiment, the cryoablation device 12 furtherincludes a shaft 32 that is longitudinal movable within a lumen of theelongate body 24, such that the shaft 32 may be advanced or retractedwithin the elongate body 24, and this movement of the shaft 32 mayaffect the shape and configuration of the treatment element(s) 14. Forexample, the cryoablation device 12 may include one treatment element14, and the shaft 32 may be fully advanced when the treatment element 14is deflated and in a delivery (or first) configuration wherein thetreatment element 14 has a minimum diameter suitable, for example, forretraction of the cryoablation device 12 within a sheath for delivery toand removal from the targeted tissue site. Conversely, when thetreatment element 14 is inflated or expanded and in a treatment (orsecond) configuration, the shaft 32 may be advanced or retracted over adistance that affects the size and configuration of the inflated orexpanded treatment element 14. Further, the shaft 32 may include aguidewire lumen through which a sensing device, mapping device,guidewire 34, or other system component may be located and extended fromthe distal end of the cryoablation device 12 (for example, from thedistal portion 36 of the shaft 32). When expanded, the treatmentelement(s) 14 are sized and configured to fit within a targetedbronchus. For example, the expanded treatment element(s) 14 may have amaximum outer diameter of between approximately 5 mm and approximately40 mm (±2 mm).

In one embodiment, the treatment element 14 includes two balloons: aninner (or first) balloon 20A and an outer (or second) balloon 20B.However, it will be understood that the treatment element 14 may includeany number of balloons. In the embodiment shown in FIG. 2, a proximalportion of the treatment element 14 is coupled to the distal portion 30of the elongate body 24 and a distal portion of the treatment element 14is coupled to a distal portion 36 of the shaft 32. The cryoablationdevice 12 also includes one or more nozzles, orifices, or other fluiddelivery elements 38 for delivering fluid (for example, coolant) to aninterior chamber 40 of the treatment element 14. For example, fluid maybe delivered to the interior chamber 40 of the inner balloon 20A and/orto the interior chamber of the outer cryoballoon 20B (that is, to theinterstitial space 42 between the inner 20A and outer 20B balloons). Forsimplicity, coolant will be referred to herein as being delivered to theinterior chamber 40 of the treatment element 14. During operation,coolant may flow from a coolant supply reservoir 44 through a coolantdelivery conduit within the elongate body 24 of the cryoablation device12 to the distal portion 30, where the coolant may then enter theinterior chamber 40 of the treatment element 14, such as through the oneor more fluid delivery elements 38, where the coolant may expand to coolthe balloon(s) 20. Expanded coolant may then pass from the interiorchamber 40 of the treatment element 14 to a coolant recovery reservoir46 and/or scavenging system through a coolant recovery conduit.

Referring now to FIGS. 3 and 4, exemplary embodiments of a cryoablationdevice 12 with at least one fluid delivery element 38 are shown. In oneembodiment, the medical device 12 is generally as shown and described inFIGS. 1 and 2, and each fluid delivery element 38 includes a fluiddelivery conduit that is wound or coiled about the shaft 32 at leastonce. In one non-limiting example, as shown in FIG. 3, the cryoablationdevice 12 includes one fluid delivery element 38 that includes aplurality of orifices 39 in the coiled portion that are radiallyarranged about the fluid delivery element 38, and in some embodimentsthe shaft 32. In one non-limiting example, the fluid delivery element 38includes twenty-four orifices 39, or more, each orifice 39 having adiameter of between approximately 0.0005 inch and approximately 0.0015inch, and the fluid delivery conduit has a diameter of betweenapproximately 0.005 inch and approximately 0.025 inch. Further, theorifices 39 are located within a center swath or equatorial portion 41of the treatment element 14 when the treatment element 14 is expanded.In one embodiment, the equatorial portion 41 corresponds to the portionof the balloon(s) 20 at which the balloon(s) 20 have the largest outerdiameter when the balloon(s) 20 are inflated, such as when theballoon(s) 20 are fully inflated. Put one way, the equatorial portion 41extends around the balloon(s) 20 of the treatment element 14 and thefluid delivery element(s) 38 are located within the treatment element 14at a location that is aligned with the equatorial portion 41. Putanother way, the equatorial portion 41 lies in a cross-sectional planeof the treatment element 14 that includes the portion of the treatmentelement having the largest outer diameter, and the fluid deliveryelement(s) 38 are located within the equatorial portion 41. Further, ifthe device includes two balloons 20, in one embodiment the equatorialportion 41 of the first balloon 20A and the equatorial portion 41 of thesecond balloon 20B are in overlapping or overlaid positions such thatthe treatment element 14 as a whole defines the equatorial portion 41.In another non-limiting example, as shown in FIG. 4, the cryoablationdevice 12 includes a first fluid delivery element 38A and a second fluiddelivery element 38B, each of which including a plurality of orifices 39in the coiled portion that are radially arranged about the fluiddelivery element, and in some embodiments the shaft 32. In onenon-limiting example, each fluid delivery element 38A, 38B includestwenty-four orifices 39, or more, each orifice 39 having a diameter ofbetween approximately 0.0005 inch and approximately 0.0015 inch and thefluid delivery conduit has a diameter of between approximately 0.005inch and approximately 0.025 inch. The embodiments shown in FIGS. 2-4are in contrast to presently known devices, such as those used foratrial fibrillation treatment procedures, which typically include afluid delivery element having eight orifices, each having a diameter of0.0025 inch. It will be understood that more than twenty-four orifices39 may be used. Thus, in some embodiments, the device of the presentdisclosure includes at least one fluid delivery element 38 with moreorifices 39 than presently known devices, and with each orifice 39having a smaller diameter than presently known devices.

Continuing to refer to FIGS. 3 and 4, the orifices 39 of both fluiddelivery elements 38A, 38B are located within a center swath orequatorial portion 41 of the treatment element 14 when the treatmentelement 14 is expanded, as discussed above regarding FIG. 3. Put anotherway, the orifices 39 are co-axially or longitudinally aligned with theequatorial portion 41. In one embodiment, the equatorial portion 41includes the portion of the balloon(s) 20 at which the balloon(s) 20have the largest outer diameter. Thus, during use, the coolant may bedelivered to the portion of the balloon(s) 20 (and in some embodimentsonly to the portion of the balloon(s) 20) that are, or are most likelyto be, in contact with the targeted tissue. The configurations shown inFIGS. 2-4 may cause coolant to be directed to the area(s) of theballoon(s) 20 (i.e. the equatorial portion 41) that are most likely tocreate circumferential lesions in bronchial tissue to achieve bronchialdenervation. Further, as each orifice 39 has a relatively smalldiameter, the increased number of orifices 39 and the placement of theorifices 39 within the equatorial portion 41 preserve coolingefficiently and total amount of coolant flow.

Referring now to FIGS. 5A-7B, further exemplary embodiments of fluiddelivery elements are shown. In the embodiments shown in FIGS. 5A-7B,the fluid delivery element 38 is a plurality of orifices 39 within theshaft 32 (that is, extending through a wall of the shaft 32 from anouter surface to a lumen within the shaft 32), rather than including afluid delivery conduit wound about the shaft, as shown in FIGS. 3 and 4.However, it will be understood that the orifices 39 of the fluiddelivery conduits 38 shown in FIGS. 2-4 may have the configuration(s)shown in FIGS. 5A-7B. For example, in one embodiment the orifices 39 areradially arranged about an entirety of the circumference of the fluiddelivery element 38 (such as in a configuration shown in FIGS. 5A and5B), in one embodiment the orifices 39 are radially arranged about aportion of the circumference of the fluid delivery element 38 (such asin a configuration shown in FIGS. 6A and 6B), and in one embodiment theorifices 39 are helically or spirally arranged about at least a portionof the circumference of the fluid delivery element 38 (such as in aconfiguration shown in FIGS. 7A and 7B). Likewise, the fluid deliveryconduits 38 shown in FIGS. 5A-7B may include the number of orifices 39and/or placement within the equatorial portion 41 of the balloon(s) 20as discussed above regarding FIGS. 2-4.

In the embodiment shown in FIGS. 5A and 5B, the fluid delivery element38 is a plurality of orifices 39 within the shaft 32, and the pluralityof orifices 39 are arranged such that the orifices 39 circumscribe theshaft 32 at at least one location. In one embodiment, the plurality oforifices 39 are within a distal portion of the shaft 32 that is at leastpartially located within the balloon 20. This configuration produces acircular fluid delivery pattern onto the inner surface of the balloon 20(in one embodiment, onto the inner surface of the inner balloon 20A) tocreate a circular lesion in the bronchial tissue, such as that shown inFIG. 14. In the embodiment shown in FIGS. 6A and 6B, the fluid deliveryelement 38 is a plurality of orifices 39 within the shaft 32, and theplurality of orifices 39 are arranged such that the orifices 39partially circumscribe the shaft 32 at at least one location. In oneembodiment, the orifices 39 extend around approximately half of thecircumference of the shaft 32, and produce a semi-circular fluiddelivery pattern onto the inner surface of the balloon 20 (in oneembodiment, onto the inner surface of the inner balloon 20A) to create asemi-circular lesion in the bronchial tissue, such as that shown in FIG.15. In the embodiment shown in FIGS. 7A and 7B, the fluid deliveryelement 38 is a plurality of orifices 39 within the shaft 32, and theplurality of orifices 39 are arranged such that the orifices 39 extendaround the shaft 32 at least once in a helical or spiral arrangement atat least one location on the shaft 32. This configuration produces ahelical or spiral fluid delivery pattern onto the inner surface of theballoon 20 (in one embodiment, onto the inner surface of the innerballoon 20A) to create helical or spiral lesion in the bronchial tissue,such as that shown in FIG. 17. Although the embodiments of FIGS. 5A-7Beach include a plurality of orifices 39 within the shaft 32 (that is,extending through the shaft wall), it will be understood that the fluiddelivery element 38 may have other shapes or configurations, such as aseparate fluid delivery element 38 that wraps around shaft 32, as shownin FIG. 1, to produce the same fluid delivery patterns discussed herein.

In another embodiment, as shown in FIGS. 8 and 9, the treatment element14 includes a plurality of splines 48 that are arranged about theelongate body longitudinal axis 26 and a single balloon 20 having aplurality of lobes 50 that are radially arranged about the elongate bodylongitudinal axis 26, between the splines 48. The splines 48 may becomposed of a material that is less thermally conductive than theballoon 20. In one embodiment, the lobes 50 are elongate and extendparallel to the elongate body longitudinal axis 26. Alternatively, thetreatment element 14 may include a plurality of individual balloons 20radially arranged about the elongate body longitudinal axis 26 andbetween the splines 48, each of the plurality of balloons 20 forming alobe 50. Alternatively, the treatment element 14 may include a singleballoon 20 that is not manufactured or constructed with lobes but, wheninflated, extends from the elongate body 24 in the areas between thesplines 48 to create a plurality of lobed areas 50 of the treatmentelement 14. In one embodiment, the lobes 50 and the splines 48 extendparallel to the elongate body longitudinal axis 26. Unlike the balloonsshown in FIG. 2, both the distal portion(s) and the proximal portion(s)of the balloon(s) 20 (and the splines 48) of the embodiment of FIGS. 8and 9 are coupled to the distal portion 30 of the elongate body 24, andare not coupled to a shaft 32. However, it will be understood that thecryoablation device 12 shown in FIGS. 8 and 9 may include a shaft 32, atleast a portion of which is coupled to the balloon(s) 20 and/or thesplines 48. During use, coolant is circulated within the balloon(s) 20to cool the balloon(s) to a temperature that is sufficient to cryoablateand, consequently, denervate adjacent targeted tissue.

In another embodiment, as shown in FIGS. 10-12, the treatment element 14includes a flexible segment 52 that is transitionable between a delivery(or first) configuration in which the flexible segment 52 is in alinear, or at least substantially linear, configuration, and an expanded(or second) configuration in which the flexible segment 52 is in ahelical (for example, as shown in FIG. 10), spiral, curvilinear, orother configuration. The flexible segment 52 is composed of a thermallyconductive material and includes one or more lumens or expansionchambers therein (referred to as the interior chamber 40), such thatcoolant is circulated within the flexible segment 52 to cool theflexible segment 52 to a temperature that is sufficient to cryoablatedand, consequently, denervate adjacent targeted tissue. In the embodimentshown in FIG. 10, the flexible segment 52 is composed of a shape-memorymaterial or a material that is biased toward the expanded configuration(or includes therein a shaping element, the shape of which controls theshape of the flexible segment 52) such that the flexible segment 52transitions from the delivery configuration to the expandedconfiguration when extended out of the elongate body 24 and/or adelivery sheath.

The cryoablation device 12 shown in FIGS. 11 and 12 includes a shaft 53slidably disposed within the elongate body 24 or coupled to the outsideof, and slidably movable with respect to, the elongate body 24 (forexample, as shown in FIGS. 11 and 12). In one embodiment, the shaft 53is movably coupled to the elongate body 24 using one or more couplingelements 54, such as rings, annular guides, or the like. Further, theflexible segment 52 includes a distal portion 55 that is fixedly coupledto both the shaft 53 and the elongate body distal portion 30. Retractionof the shaft 53 within or relative to the elongate body 24 causes theflexible segment 52 to transition between the delivery configuration andthe expanded configuration.

In either the embodiment of FIG. 10 or that of FIGS. 11 and 12, theflexible segment 52 has a size and shape of the bronchus to be treated.Further, the flexible segment 52, when in the expanded configuration,may have a helical shape with any number of windings. In one embodiment,the flexible segment 52 includes one winding. In another embodiment, theflexible segment 52 includes a plurality of windings. However, it willbe understood that the cryoablation device 12 may include a treatmentelement 14 of any suitable size, number, shape, or configuration forablating tissue from within a bronchus of a lung.

In any embodiment, the cryoablation device 12 optionally may include atleast two recording electrodes 56 capable of stimulating tissue,sensing, and/or recording electrical action potential signals fromwithin the smooth muscle tissue of the bronchi. The recordingelectrode(s) 56 are in communication with and transmit signals to theelectromyography system 18, which interprets those signals andcommunicates them to the user, as is discussed in greater detail below.In one embodiment, the cryoablation device 12 includes a first recordingelectrode 56A located distal to the treatment element 14 and a secondrecording electrode 56B located proximal to the treatment element 14(for example, as shown in FIGS. 2, 8, and 10-12). Each recordingelectrode 56 records the smooth muscle action potential, and thecombined electromyogram signal represents a potential (voltage)difference between the action potentials recorded by the electrodes. Inone embodiment, the first recording electrode 56A is coupled to thedistal portion 55 of the flexible segment 52 and the second recordingelectrode 56B is coupled to the elongate body distal portion 30 (forexample, as shown in FIG. 10). In another embodiment, the firstrecording electrode 56A is coupled to the distal portion of the shaft 53and the second recording electrode 56B is coupled to the shaft 53 at alocation proximal to the first recording electrode 56A (for example, asshown in FIGS. 11 and 12). However, it will be understood that therecording electrodes 56 may be at any suitable location on thecryoablation device 12.

Referring again to FIG. 1, the electromyography system 18 includes oneor more controllers, processors, and/or software modules containinginstructions or algorithms to provide for the automated operation andperformance of the features, sequences, or procedures described herein.In one embodiment, for example, the electromyography system 18 includesprocessing circuitry 57 with a memory and a processor. The memory is inelectrical communication with the processor and includes instructionsthat, when executed by the processor, configure the processor toreceive, process, or otherwise use signals from the cryoablation device12 and/or other system components. Still further, the electromyographysystem 18 may include one or more user input devices, controllers,speakers, and/or displays 58 for collecting and conveying informationfrom and to the user. Additionally or alternatively, theelectromyography system 18 may be in communication with the control unit16 such that information is received and/or communicated from theelectromyography system 18 to the user through the control unit 16.

In one non-limiting example, the processing circuitry 57 of theelectromyography system 18 is configured to receive data (for example,electrical action potential signals) from the recording electrodes 56 ofthe cryoablation device 12 and to convert that data into informationthat can be conveyed to the user, such as a visual display, an audiosignal, or the like. Further, the processing circuitry 57 of theelectromyography system 18 may be configured to compare data receivedfrom the recording electrodes 56 to one or more reference values orranges and generate an alert based on the comparison. For example, theprocessing circuitry of the electromyography system 18 may compareelectrogram signal voltage and/or electromyogram signal amplitude overtime (AOT) received from the recording electrodes to a threshold orreference electrogram signal voltage and/or electromyogram signal AOTthat indicates denervation has occurred. If the received electromyogramsignal voltage and/or AOT is within a threshold range of the referenceelectromyogram signal voltage and/or AOT, the processing circuitry maythen generate and communicate an alert (such as a visual display oraudio tone) to the user that indicates denervation has occurred and theuser may cease the cryoablation procedure. Additionally, the processingcircuitry 57 of the electromyography system 18 may be configured tocalculate a time to denervation based on the difference between thereceived and the reference electromyography signal voltage and/or AOTs,so the user can know how much longer the cryoablation procedure shouldcontinue.

As used herein, the term “control unit” for simplicity may include anysystem components that are not part of the cryoablation device 12itself, other than components of the electromyography system 18,regardless of whether the component is physically located within orexternal to the control unit 16. Further, the electromyography system 18may be a standalone system in communication with the control unit 16 ormay be contained within or integrated with the control unit 16, eventhough it is shown as being physically separated from the control unit16 in FIG. 1. In one embodiment, the control unit 16 includes a coolantsupply reservoir 44, a coolant recovery reservoir 46 or an exhaust orscavenging system for recovering or venting expended fluid for re-use ordisposal, as well as various control mechanisms. In addition toproviding an exhaust function for the coolant supply, the control unit16 may also include pumps, valves, controllers or the like to recoverand/or re-circulate fluid delivered to the elongate body 24 and/or thefluid pathways of the system. Further, the control unit 16 may include avacuum pump 60 for creating a low-pressure environment in one or moreconduits within the cryoablation device 12 so that coolant is drawn intothe conduit(s)/lumen(s) of the elongate body 24, away from the distalportion 30 and towards the proximal portion 28 of the elongate body 24.

In one embodiment, the control unit 16 includes one or more controllers,processors, and/or software modules containing instructions oralgorithms to provide for the automated operation and performance of thefeatures, sequences, or procedures described herein. In one embodiment,for example, the control unit 16 includes processing circuitry 62programmed or programmable to execute the automated or semi-automatedoperation and performance of the features, sequences, calculations, orprocedures described herein. In one embodiment, for example, the controlunit 16 includes processing circuitry 62 with a memory and a processor.The memory is in electrical communication with the processor andincludes instructions that, when executed by the processor, configurethe processor to receive, process, or otherwise use signals from thecryoablation device 12 and/or other system components. Still further,the control unit 16 may include one or more user input devices,controllers, speakers, and/or displays 64 for collecting and conveyinginformation from and to the user.

Although not shown, the medical system 10 may include one or moresensors to monitor the operating parameters through the medical system10, such as pressure, temperature, coolant flow rate, or the like. Thesensor(s) may be in communication with the control unit 16 forinitiating or triggering one or more alerts or coolant deliverymodifications during operation of the cryoablation device 12.

Referring now to FIG. 20, with reference to FIGS. 13-19, an exemplarymethod of performing bronchial denervation using a cryoablation device12 is shown. In a first step 101, a treatment element 14 of acryoablation device 12 is positioned within a bronchus 66 of thepatient's lung at a location proximate a targeted area of tissue (forexample, as shown in FIG. 13). In a second step 102, the treatmentelement 14 of the cryoablation device 12 is inflated, expanded, orotherwise manipulated such that at least a portion of the treatmentelement 14 is brought into contact with at least a portion of thetargeted area of tissue.

In a third step 103, the recording electrodes 56 are positioned suchthat they are in contact with the targeted area of tissue and are usedto record electromyogram signals (smooth muscle action potentialsignals) from the targeted area of tissue. Further, the electrogramsignals may be recorded by the recording electrodes before, during,and/or after a cryoablation procedure. Thus, the third step 103 mayoccur at any time during the method.

In a fourth step 104, coolant is delivered from the coolant supplyreservoir 44 to the treatment element 14 and circulated within thetreatment element 14 to reduce the temperature of the treatment element14 to a temperature sufficient to cryoablate tissue that is in contactwith the treatment element 14. As noted above, the recording electrodes56 may continue to record electromyogram signals from the bronchialtissue over the time during which coolant is circulated within thetreatment element 14 (that is, during the cryoablation procedure). Thisis indicated as step 103 in FIG. 20; however, it will be understood thatthis step may be performed at the same time as, before, and/or after thefourth step 104. Non-limiting examples of ablation patterns createdwithin bronchial tissue by a treatment element 14 are shown in FIGS.14-17. For example, using a treatment element 14 such as that shown anddescribed in FIGS. 1 and 2 (that is, at least one balloon 20 withoutlobes) that has, in one embodiment, a fluid delivery element 38 with acircular fluid delivery pattern (as shown in FIGS. 5A and 5B), maycreate a circumferential lesion 68A within the bronchial tissue 66, astylized representation of which is shown in FIG. 14; using a treatmentelement 14 such as that shown and described in FIGS. 1 and 2 that has,in one embodiment, a fluid delivery element 38 with a semi-circularfluid delivery pattern (as shown in FIGS. 6A and 6B), may create apartially circumferential or semi-circular lesion 68B (for example, asemi-circular lesion) within the bronchial tissue 66, a stylizedrepresentation of which is shown in FIG. 15; using a treatment element14 such as that shown and described in FIGS. 8 and 9 (that is, a balloonwith lobes 50 or several balloons forming lobed areas 50) may create aseries of lesions 68C within the bronchial tissue 66, a stylizedrepresentation of which is shown in FIG. 16, or an interruptedcircumferential lesion such as that shown in FIG. 14; and using atreatment element 14 such as shat shown and described in FIG. 10 (thatis, a flexible segment 52 transitionable to a helical configuration) ora treatment element 14 such as that shown and described in FIGS. 1 and 2that has, in one embodiment, a fluid delivery element 38 with a spiralor helical fluid delivery pattern (as shown in FIGS. 7A and 7B) maycreate a helical lesion 68D in the bronchial tissue 66, a stylizedrepresentation of which is shown in FIG. 17.

Here, the third step 103 may again be performed. The electromyogramsignals are transmitted from the recording electrodes 56 to theelectromyography system 18. Additionally, these signals may becontinually recorded and transmitted before, during, and after thecryoablation procedure. The processing circuitry 57 of theelectromyography system 18 then uses the received electromyogram signalsto make one or more comparisons and determinations (thus, the receivedelectromyogram signals may be referred to as being raw electromyogramsignals). For example, in a fifth step 105, the processing circuitry 57of the electromyography system 18 calculates a difference between atleast one electromyogram signal received from a first recordingelectrode 56A and at least one electromyogram signal received from asecond recording electrode 56B. In one non-limiting example, theprocessing circuitry 57 of the electromyography system 18 calculates avoltage difference between received or raw electrogram signalstransmitted from the recording electrodes during the cryoablationprocedure and generates a recorded electromyogram 70. Thus, the recordedelectromyogram 70 includes voltage difference(s) over time. For example,FIG. 18 shows a recorded electromyogram 70A recorded before denervationoccurs (that is, recorded before the cryoablation procedure and/orduring the cryoablation procedure, before denervation occurs). As notedabove, the recording electrodes 56 may continue to record electrogramsignals during and/or after the cryoablation procedure, and theprocessing circuitry 57 of the electromyography system 18 may continueto generate recorded electromyograms 70.

Further, in one embodiment, the processing circuitry 57 of theelectromyography system 18 is configured to compare a recordedelectromyogram 70 generated from electromyogram signals received beforethe cryoablation procedure with a recorded electromyogram 70 generatedfrom electromyogram signals received during and/or after thecryoablation procedure, and to use this comparison to determine whetherdenervation of the bronchial tissue 66 has occurred (such as in a sixthstep 106). In one non-limiting example, if the difference in recordedelectromyograms (such as a voltage difference) exceeds a thresholddifference, the processing circuitry 57 of the electromyography system18 may determine that denervation has occurred (such as in a seventhstep 107). Additionally or alternatively, the processing circuitry 57electromyography system 18 is configured to compare a recordedelectromyogram 70 generated from electromyogram signals received duringand/or after a cryoablation procedure with a reference electromyogramthat indicates denervation has occurred. If the recorded electromyogram70 is the same as, or is within a threshold range or difference of, thereference electromyogram, the processing circuitry 57 of theelectromyography system 18 may determine that denervation has occurred(such as in a seventh step 107). For example, FIG. 19 shows a recordedelectromyogram 70B after denervation has occurred, in which theattenuated electromyogram voltage is shown.

In an eighth step 108, the processing circuitry 57 of theelectromyography system 18 generates an alert when it determines thatdenervation has occurred. In one non-limiting example, theelectromyography system 18 generates an audible and/or visual alert thatcommunicates to the user that denervation has occurred and gives theuser the opportunity to discontinue the cryoablation procedure (forexample, to discontinue or reduce the circulation of coolant within thetreatment element 14). Additionally or alternatively, theelectromyography system 18 generates an alert in the form of alert dataand transmits this data to the control unit 16. The control unit 16 maythen communicate the alert (for example, audible and/or visual alert) tothe user to prompt the user to manually discontinue the cryoablationprocedure, and/or the control unit 16 may automatically discontinue orreduce the circulation of coolant within the treatment element 14 to endthe cryoablation procedure.

It will be appreciated by persons skilled in the art that the presentembodiments are not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

In one or more examples, the described techniques may be implemented inhardware, software, firmware, or any combination thereof. If implementedin software, the functions may be stored as one or more instructions orcode on a computer-readable medium and executed by a hardware-basedprocessing unit. Computer-readable media may include non-transitorycomputer-readable media, which corresponds to a tangible medium such asdata storage media (e.g., RAM, ROM, EEPROM, flash memory, or any othermedium that can be used to store desired program code in the form ofinstructions or data structures and that can be accessed by a computer).

Instructions may be executed by one or more processors, such as one ormore digital signal processors (DSPs), general purpose microprocessors,application specific integrated circuits (ASICs), field programmablelogic arrays (FPGAs), or other equivalent integrated or discrete logiccircuitry. Accordingly, the term “processor” as used herein may refer toany of the foregoing structure or any other physical structure suitablefor implementation of the described techniques. Also, the techniquescould be fully implemented in one or more circuits or logic elements.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope andspirit of the invention, which is limited only by the following claims.

What is claimed is:
 1. A method for performing bronchial denervation,the method comprising: an electromyography system having a cryoablationdevice with at least two recording electrodes, the electromyographysystem being configured to: calculate a difference between a firstelectromyogram signal received from the first recording electrode and asecond electromyogram signal received from the second recordingelectrode to generate a recorded electromyogram; and compare therecorded electromyogram to a reference electromyogram.
 2. The method ofclaim 1, further comprising transmitting the first electromyogram signaland the second electromyogram signal to the electromyography system. 3.The method of claim 2, wherein the at least two recording electrodesincludes a first recording electrode and a second recording electrode,when the cryoablation device is performing a cryoablation procedure thefirst recording electrode and the second recording electrode arecontinuously transmitting signals to the electromyography system.
 4. Themethod of claim 1, wherein the method further includes calculating avoltage difference between the first electromyogram signal and thesecond electromyogram signal.
 5. The method of claim 1, wherein the atleast two recording electrodes includes a first recording electrode anda second recording electrode and before the cryoablation device isperforming a cryoablation procedure, the first recording electrode andthe second recording electrode are continuously transmitting signals tothe electromyography system.
 6. The method of claim 5, wherein the atleast two recording electrodes includes a first recording electrode anda second recording electrode and while the cryoablation device performsa cryoablation procedure and after the cryoablation device performs acryoablation procedure, the first recording electrode and the secondrecording electrode are continuously transmitting signals to theelectromyography system.
 7. The method of claim 1, wherein the at leasttwo recording electrodes includes a first recording electrode and asecond recording electrode and the calculation further includes:calculating a difference between the first electromyogram signalreceived from the first recording electrode and the secondelectromyogram signal received from the second recording electrodebefore a cryoablation procedure to generate a first recordedelectromyogram; and calculating the difference between the firstelectromyogram signal received from the first recording electrode andthe second electromyogram signal received from the second recordingelectrode after cryoablation to generate a second recordedelectromyogram.
 8. The method of claim 7, further comprising calculatingthe difference between the first recorded electromyogram and the secondrecorded electromyogram.
 9. The method of claim 8, further comprisingcomparing the calculated difference between the first recordedelectromyogram and the second recorded electromyogram with a referenceelectromyogram.
 10. The method of claim 9, further comprisingdetermining whether denervation has occurred based on the comparisonbetween the difference between the first recorded electromyogram and thesecond recorded electromyogram with the reference electromyogram. 11.The method of claim 10, wherein the electromyography system determinesthat denervation has occurred when the comparison between the differencebetween the first recorded electromyogram and the second recordedelectromyogram with the reference electromyogram exceeds a thresholddifference.
 12. The method of claim 11, further comprising generating analert when the electromyography system determines that denervation hasoccurred.
 13. The method of claim 12, wherein the alert is an audible orvisual alert.
 14. A method for performing bronchial denervation, themethod comprising: a cryoablation device including a treatment elementand a first recording electrode and a second recording electrode; anelectromyography system in communication with the at least the firstrecording electrode and the second recording electrode, theelectromyography system including processing circuitry configured to:receive electromyogram signals from the first recording electrode andthe second recording electrode; calculate a difference between a firstelectromyogram signal received from the first recording electrode and asecond electromyogram signal received from the second recordingelectrode to generate a recorded electromyogram; and compare therecorded electromyogram to a reference electromyogram.
 15. The system ofclaim 14, wherein the processing circuitry is further configured todetermine whether denervation has occurred in an area of tissue based onthe comparison between the recorded electromyogram and the referenceelectromyogram.
 16. The system of claim 14, wherein the processingcircuitry is further configured to generate an alert when the processingcircuitry has determined that denervation has occurred in an area oftissue.
 17. A method for performing bronchial denervation, the methodcomprising: positioning a treatment element proximate an area oftargeted tissue; expanding the treatment element such that at least aportion of the treatment element is in contact the area of targetedtissue; circulating a coolant within the treatment element to reduce atemperature of the treatment element to a temperature sufficient tocryoablate at least a portion of the area of targeted tissue; recordingat least one electromyogram signal from the at least a portion of thearea of targeted tissue with each of a first recording electrode and asecond recording electrode; transmitting the recorded at least oneelectromyogram signal to an electromyography system; calculating adifference between the at least one electromyogram signal received fromthe first recording electrode and the at least one electromyogram signalreceived from the second recording electrode to generate a recordedelectromyogram; and comparing the recorded electromyogram to a referenceelectromyogram.
 18. The method of claim 17, further comprising:determining whether denervation has occurred in the at least a portionof the area of targeted tissue based on the comparison; anddiscontinuing the circulation of the coolant within the treatmentelement when it is determined that denervation has occurred in the areaof targeted tissue.
 19. The method of claim 18, further comprising:generating an alert when it is determined that denervation has occurredin the at least a portion of the area of targeted tissue.
 20. The methodof claim 17, wherein the electromyography system further includesprocessing circuitry configured to determine whether denervation hasoccurred in the area of targeted tissue based on the comparison betweenthe recorded electromyogram and the reference electromyogram.